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Interventionist training and intervention fidelity monitoring and maintenance for CONNECT, a nurse-led primary palliative care in oncology trial.

ABSTRACT: Context:Intervention fidelity is a critical component of behavioral research that has received inadequate attention in palliative care studies. With increasing focus on the need for palliative care models that can be widely disseminated and delivered by non-specialists, rigorous yet pragmatic strategies for training interventionists and maintaining intervention fidelity are needed. Objectives:(1) Describe components of a plan for interventionist training and monitoring and maintaining intervention fidelity as part of a primary palliative care trial (CONNECT) and (2) present data about perceived training effectiveness and delivery of key intervention content. Methods:Post-training evaluations, visit checklists, and visit audio-recordings. Results:Data were collected from June, 2016 through April, 2017. We include procedures for (1) identification, training and certification of oncology nurses as CONNECT interventionists; (2) monitoring intervention delivery; and (3) maintaining intervention quality. All nurses (N?=?14) felt prepared to deliver key competencies after a 3-day in-person training. As assessed via visit checklists, interventionists delivered an average of 94% (SD 13%) of key content for first intervention visits and 85% (SD 14%) for subsequent visits. As assessed via audio-recordings, interventionists delivered an average of 85% (SD 8%) of key content for initial visits and 85% (SD 12%) for subsequent visits. Conclusion:We present a 3-part strategy for training interventionists and monitoring and maintaining intervention delivery in a primary palliative care trial. Training was effective in having nurses feel prepared to deliver primary palliative care skills. As assessed via nursing checklists and visit audio-recordings, intervention fidelity was high.

SUBMITTER: Robbins-Welty GA

PROVIDER: S-EPMC5898502 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Interventionist training and intervention fidelity monitoring and maintenance for CONNECT, a nurse-led primary palliative care in oncology trial.

Robbins-Welty Gregg A GA Mueser Lisa L Mitchell Chandler C Pope Nicole N Arnold Robert R Park SeoYoung S White Doug D Smith Kenneth J KJ Reynolds Charles C Rosenzweig Margaret M Bakitas Marie M Schenker Yael Y

Contemporary clinical trials communications 20180315

<h4>Context</h4>Intervention fidelity is a critical component of behavioral research that has received inadequate attention in palliative care studies. With increasing focus on the need for palliative care models that can be widely disseminated and delivered by non-specialists, rigorous yet pragmatic strategies for training interventionists and maintaining intervention fidelity are needed.<h4>Objectives</h4>(1) Describe components of a plan for interventionist training and monitoring and maintai ...[more]

PMID: 29696159

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Project description:ImportanceGuidelines recommend early specialty palliative care for all patients with advanced cancer, but most patients lack access to such services.ObjectiveTo assess the effect of CONNECT (Care Management by Oncology Nurses to Address Supportive Care Needs), a primary palliative care intervention delivered by oncology nurses, on patient outcomes.Design, setting, and participantsThis cluster randomized clinical trial of the CONNECT intervention vs standard care was conducted from July 25, 2016, to October 6, 2020. Participants were adult patients with metastatic solid tumors who were undergoing oncological care and for whom an oncologist would agree with the statement "would not be surprised if the patient died in the next year." The trial was conducted at 17 community oncology practices in western Pennsylvania. Data analyses adhered to the intention-to-treat principle.InterventionsThe CONNECT intervention included 3 monthly visits with an existing infusion room nurse who was trained to address symptoms, provide emotional support, engage in advance care planning, and coordinate care.Main outcomes and measuresThe primary outcome was quality of life. At baseline and 3 months, participants completed assessments of quality of life (Functional Assessment of Chronic Illness Therapy-Palliative care: score range, 0-184, with higher scores indicating better quality of life), symptom burden (Edmonton Symptom Assessment Scale: score range, 0-90, with higher scores indicating greater symptom burden), and mood symptoms (Hospital Anxiety and Depression Scale [HADS]: score range, 0-21, with higher scores indicating substantial anxiety and depression). Linear mixed-effects models were used to estimate adjusted mean differences in 3-month outcomes. Preplanned, intensity-adjusted analyses were conducted.ResultsA total of 672 patients were enrolled (mean [SD] age, 69.3 [10.2] years; 360 women [53.6%]). The mean (SD) number of CONNECT visits completed was 2.2 (1.0). At 3 months, no difference in mean (SD) quality-of-life score was found between the CONNECT and standard care groups (130.7 [28.2] vs 134.1 [28.1]; adjusted mean difference, 1.20; 95% CI, -2.75 to 5.15; P = .55). Similarly, there was no difference between groups in 3-month mean (SD) symptom burden (23.2 [16.6] vs 24.0 [16.1]; adjusted mean difference, -2.64; 95% CI, -5.85 to 0.58; P = .11) or mood symptoms (HADS depression subscale score: 5.1 [3.4] vs 4.8 [3.7], adjusted mean difference, -0.08 [95% CI, -0.71 to 0.57], P = .82; HADS anxiety subscale score: 5.7 [3.9] vs 5.4 [4.2], adjusted mean difference, -0.31 [95% CI, -0.96 to 0.33], P = .34). Intensity-adjusted analyses revealed a larger estimated treatment effect for patients who received a full dose (3 visits) of the CONNECT intervention.Conclusions and relevanceThis cluster randomized clinical trial found that a primary palliative care intervention that was delivered by oncology nurses did not improve patient-reported outcomes at 3 months. Primary palliative care interventions with a higher dose intensity may be beneficial for most patients with advanced cancer who lack access to palliative care specialists.Trial registrationClinicalTrials.gov Identifier: NCT02712229.

Project description:BACKGROUND:Technology-based lifestyle behavioral interventions (i.e., telehealth, mHealth, eHealth, and/or digital health) are becoming an alternative standard of care and possess several advantages over traditional clinical settings such as convenience, cost, and the ability to tailor plans and feedback to a participant's individual needs. These technology-based interventions also present unique challenges to intervention fidelity due to extra elements involved in executing the intervention. Intervention fidelity monitoring is essential to ensure internal and external validity, yet the development and utilization of fidelity protocols is under-reported in the literature. The purpose of this paper is to describe the intervention fidelity protocol for the 24-START study, a behavior change intervention delivered through telephone and internet. This paper also discusses the results of a pilot audit conducted to determine the feasibility of monitoring adherence to the fidelity protocol. METHODS:The 24-START fidelity protocol was developed in accordance with the five fidelity areas outlined by the NIH Behavior Change Consortium (NIH BCC) including: design of study, provider training, delivery of treatment, receipt of treatment, and enactment of treatment. The fidelity strategies provided by the NIH BCC in each area were tailored to fit the specific design of the 24-START study. Twenty-six total fidelity strategies were developed in accordance with the five areas and a corresponding fidelity monitoring plan was created. Because these strategies are only beneficial if implemented, the fidelity monitoring plan was developed to ensure the fidelity strategies are consistently implemented over the course of the intervention. RESULTS:A pilot audit of nine participant files was conducted to test the feasibility of the fidelity protocol developed. Out of the nine participant files reviewed, 89% of scheduled phone calls between a telehealth coach and participant were successfully completed. Of the completed calls, telehealth coaches delivered the intervention as intended 85.3% of the time, and 74% of planned secondary contacts made through the internet were delivered successfully. Additionally, between treatment group dosing was found to be equal. Several weak areas in the fidelity protocol were identified for improvement. The results were satisfactory and the audit was deemed feasible for ongoing use. CONCLUSIONS:The NIH BCC provides a valuable framework for telehealth interventions to develop fidelity protocols ultimately contributing to improved internal and external validity, better translation of results, increased transparency, and increased opportunities for replication within the field. The 24-START pilot audit found the fidelity protocol efficacious and feasible while also identifying areas of weakness in need of revision. The refined protocol will continue to be utilized throughout the data collection phase. Future telehealth interventions should develop and disclose fidelity protocols to improve the overall quality and standard of telehealth interventions.

Dataset Information

Interventionist training and intervention fidelity monitoring and maintenance for CONNECT, a nurse-led primary palliative care in oncology trial.

Publications

Interventionist training and intervention fidelity monitoring and maintenance for CONNECT, a nurse-led primary palliative care in oncology trial.

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